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A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
This study has been completed.
First Received: February 6, 2007   Last Updated: November 15, 2007   History of Changes
Sponsored by: Adventrx Pharmaceuticals
Information provided by: Adventrx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00432562
  Purpose

This study is a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective is to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.


Condition Intervention Phase
Breast Cancer
Non-Small Cell Lung Cancer
Non-Hodgkins Lymphoma
Drug: Vinorelbine Tartrate
Phase I

Study Type: Interventional
Study Design: Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
Official Title: A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.

Resource links provided by NLM:


Further study details as provided by Adventrx Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence with reference product.

Estimated Enrollment: 28
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • Advanced cancer potentially sensitive to vinorelbine:
  • Breast cancer.
  • Stage 3 or 4 non-small cell lung cancer.
  • Non-Hodgkins lymphoma.
  • Cancer of other histologic type, sensitive to vinca alkaloids.
  • Rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy.
  • Failure of standard treatment(s) of the tumor.
  • Life expectancy of at least three months.
  • ECOG performance level 0-2 or Karnofsky score 100-70.
  • Hematological and serum chemistry results with defined ranges.
  • Willingness and ability to provide written informed consent.

Exclusion Criteria:

  • Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. A postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months.
  • Previous treatment with vinorelbine or mitomycin.
  • Any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment.
  • Active infection.
  • Prior anticancer therapy completed within four weeks prior to the first day of study treatment.
  • Failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded).
  • Participation in another experimental drug study within four weeks prior to the first day of study treatment.
  • Requirement for any concomitant chemotherapeutic agent other than the study medication.
  • Any investigator judgment that the individual would not be an appropriate study subject.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432562

Locations
Argentina
Clinical Investigative Site
Rosario, Argentina
Clinical Investigative Site
Tucuman, Argentina
Clinical Investigative Site
Santa Fe, Argentina
Clinical Investigative Site
Buenos Aires, Argentina
Clinical Investigative Site
Mendoza, Argentina
Sponsors and Collaborators
Adventrx Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: 530-01
Study First Received: February 6, 2007
Last Updated: November 15, 2007
ClinicalTrials.gov Identifier: NCT00432562     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Thoracic Neoplasms
Immunoproliferative Disorders
Skin Diseases
Breast Neoplasms
Vinblastine
Antimitotic Agents
Carcinoma
Lymphoma, Small Cleaved-cell, Diffuse
Hydroxyzine
Lymphatic Diseases
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Lymphoma
Carcinoma, Non-Small-Cell Lung
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vinblastine
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lymphoma
Breast Diseases
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunoproliferative Disorders
Skin Diseases
Immune System Diseases
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Lymphatic Diseases
Neoplasms
Vinorelbine
Lung Diseases
Tubulin Modulators
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009